Z-0389-2021Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup...
Zimmer GmbH / initiated 2020-09-24 / Terminated / root cause: design
Zimmer Biomet, Inc. began a recall of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-28 on . FDA classified it as Class II and gives the reason as "Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0389-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-28
- Product code
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Reason for recall
- Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL AND NOTICE OF US FIELD DISCONTINUATION letter to Distributors. Risk Manages, Physicianson/ 9/24/20 stating reason for recall, heath risk and action to take: 1.Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
- Quantity in commerce
- 412 units total
- Distribution
- US Nationwide
- Product codes and lots
- All lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0323-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0324-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0325-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0326-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0327-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0328-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0329-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0330-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0331-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0332-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0333-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0334-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0335-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0336-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0337-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0338-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0339-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0340-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0341-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0342-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0343-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0344-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0345-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0346-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0347-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0348-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0349-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0350-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0351-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0352-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0353-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0354-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0355-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0356-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0357-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0358-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0359-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0360-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0361-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0362-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0363-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0364-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0365-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0366-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0367-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0368-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0369-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0370-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0371-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0372-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0373-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0374-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0375-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0376-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0377-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0378-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0379-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0380-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0381-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0382-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0383-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0384-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0385-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0386-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0387-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0388-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0389-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0390-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0391-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0392-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0393-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0394-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0395-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0396-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0397-2021 | Class II | Terminated | Voluntary: Firm initiated |
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